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Topical ketoprofen TDS patch versus diclofenac gel: efficacy and tolerability in benign sport related soft-tissue injuries.
Esparza, F, Cobián, C, Jiménez, JF, García-Cota, JJ, Sánchez, C, Maestro, A, ,
British journal of sports medicine. 2007;(3):134-9
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Abstract
OBJECTIVE To compare the ketoprofen TDS patch with diclofenac gel in the treatment of traumatic acute pain in benign sport-related soft-tissue injuries. DESIGN 7-14 treatment days, prospective, randomised, open study. PATIENTS Outpatients aged 18-70 years diagnosed for painful benign sport-related soft-tissue injury (sprains, strains and contusions within the prior 48 h), randomised to either ketoprofen patch 100 mg once daily (n = 114) or diclofenac gel 2-4 g three times daily (n = 109). INTERVENTION 7-14 days of topical non-steroidal anti-inflammatory drugs treatment to assess the pain intensity changes (daily activities and spontaneous at rest) in a daily diary (100-mm Visual Analogue Scale (VAS)). MAIN OUTCOME MEASUREMENT Pain intensity (VAS). RESULTS The ketoprofen patch was not inferior to diclofenac gel in reducing the baseline pain during daily activities (difference of -1.17 mm in favour of ketoprofen patch, 95% CI (-5.86 to 3.52), reducing to the baseline VAS 79%. Ketoprofen patch presented also a higher cure rate (64%) than diclofenac gel (46%) at day 7 (p = 0.004). Patient opinions about the treatment comfort (pharmaceutical shape, application and dosage) were also statistically higher for the ketoprofen patch (>80% of the patients rated as good or excellent the patch removal and skin adherence). CONCLUSION Ketoprofen patches are effective and safe pain relievers for the treatment of sports injury pain with advantages compared with diclofenac gel.
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Escin/diethylammonium salicylate/heparin combination gels for the topical treatment of acute impact injuries: a randomised, double blind, placebo controlled, multicentre study.
Wetzel, D, Menke, W, Dieter, R, Smasal, V, Giannetti, B, Bulitta, M
British journal of sports medicine. 2002;(3):183-8
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OBJECTIVES To investigate the clinical efficacy and safety of escin-containing gels in the topical treatment of blunt impact injuries. METHODS Competitors in soccer, handball, or karate competitions were enrolled within two hours of sustaining a strain, sprain, or contusion and treated three times with the trial gel within a period of eight hours. Patients were randomised to three parallel groups consisting of two active treatment gels, containing escin (1% or 2%), 5% diethylammonium salicylate, and 5000 IU heparin, or placebo gel. Tenderness produced by pressure was measured at 0 (baseline), 1, 2, 3, 4, 6, and 24 hours after enrollment (within two hours of the injury). Tenderness was defined as the amount of pressure (measured by a calibrated caliper at the centre of the injury) that first produced a pain reaction as reported by the patient. RESULTS A total of 158 patients were enrolled; 156 were evaluated in the intention to treat analysis. The primary efficacy variable was the area under the curve for tenderness over a six hour period. The gel preparations containing 1% and 2% escin were significantly more effective (a priori ordered hypotheses testing controlling the multiple alpha = 5% significance level) than placebo (p(1) = 0.0001 and p(2) = 0.0002 respectively). The treatment effects were 5.7 kp h/cm(2) (95% confidence interval (CI) 2.9 to 8.5) and 5.9 kilopond (kp) h/cm(2) (95% CI 2.9 to 8.8) between 1% escin and placebo and between 2% escin and placebo respectively. These results were supported by secondary efficacy variables. The time to reach the baseline contralateral tenderness value (resolution of pain) at the injured site was shorter in the treatment groups than in the placebo group (p<0.0001). Both active gel preparations produced more rapid pain relief than the placebo gel. No relevant differences were detected between the two active gels. The safety and tolerability of the escin-containing gels were excellent. CONCLUSIONS Escin/diethylammonium salicylate/heparin combination gel preparations are effective and safe for the treatment of blunt impact injuries.